Our expertise in expanding your market backed by our experience in the US


The context of the US is marked by a higher freedom in establishing pharmaceutical prices what, together with the existence of some of the biggest pharma companies, continues placing the US as one of the biggest shareholders of the market. Hence, the interest in commercializing in the US is notorious for those clients wishing to boost their possibilities.

Nonetheless, the US counts with a rigid regulatory system headed by the FDA, together with CDER and CBER and the Code of Federal Regulations, among others. For a market strategy to be successful within the US context, a good and detailed understanding on how processes and standards vary, as well as having presence and contact with the regulatory authorities becomes paramount when looking for an expansion from the European market.

Our experience in the US aims at positioning your product in a valuable place to foster approval and commercialization.

USA Solutions

  • Regulatory consultancy and strategy for all regulatory procedures
    • Gap analysis and feasibility assessment
    • Regulatory roadmaps
    • Preparation and participation in strategic contacts and meetings with the FDA with support from US specialized partner:
      • Preparation of Meeting Request and Meeting Packages, as well as any requested documentation
      • Type A, B and C meetings
      • Pre-IND and EOF2 meetings
      • Management of meeting calendars and answers
  • Writing of reports: annual reports, feasibility reports and Due diligence, DMF preparation, Gap Analysis of EU dossiers for parallel development EU/US. Assistance in extending commercialization from EU to US
  • Authorization for new drug commercialization: NDA/ANDA/BLA elaboration and submission. Pre-NDA and Pre-BLA meeting management
  • Activities for IND maintenance and product maintenance; management of amendments and update of documentation
  • Medical scientific writing, including CMC, Clinical and Non-clinical information. Assistance and management of publishing activities
  • Writing and Authoring of all Technical and Scientific Documentation
  • Submission Management for all Regulatory Procedures
    • e-Submission Expert Services including FDA Electronic Gateways
  • ODD request (elaboration of application and submission)
  • Elaboration of Pediatric Study Plans (PSP)
  • Quality Management System (QMS) design and implementation for medical devices based on 21CFR 820
  • All these procedures are carried out with the support of Asphalion’s US agent, with over 20 years’ experience in the pharmaceutical and biotech industries in the US context

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Why Asphalion?

Asphalion has been working in Regulatory activities with the FDA since 2005 and has established a strategic alliance with Reguliance, a company founded by Bruce Thompson specialized in providing regulatory support and project management to drug and biotech firms.

For the last 3 years, ASPHALION has managed over 70 projects involving the preparation, submission and/or maintenance of different types of applications for US, including Pre-IND meetings, INDs, NDAs, BLAs, ANDAs, DMFs, ODD and PSPs, in direct contact with the FDA.

Main benefits

  • Over 10 years of successful collaboration
  • Complementary services
  • Joint customers throughout Europe
  • Expertise in a wide variety of products and therapeutic areas
  • Own US agent with more than 20 years on the pharmaceutical sector
  • Over 70 US projects

Related Resources

Structure-Data File Format (SD)

Structure-Data File Format (SD)

Since 1st October 2022, applicants may now submit chemical structures as a single Structure-Data File format.
Are you holding a dossier in US? If the answer is YES, this brochure may be of your interest!

Flyer ATMPs Asphalion


Scientific & Regulatory Affairs Support during development of ATMPs & Biologics

New study data update by FDA Asphalion

New study data update by FDA

Beginning 15th September 2021
, FDA will enforce the
TechnicalRejection Criteria (TRC)
for Study Data by

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